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The study consists of an investigational treatment that will be administered subcutaneously (by injection under the skin) every 4 weeks, for 32 weeks. There is no placebo for this study and all participants will be receiving the treatment. 

During the study visits, several assessments and procedures will be conducted to assess your eligibility for the study.

This study will last 1 year and will include up to 14 visits. There is a 12-week post-treatment follow-up period lasting from Week 32 to Week 48 as the final planned clinic visit. Visit duration are between 1-3.5 hours, except for your screening visit that may take up to 4 hours, your Day 1 visit that may take up to 5.5 hours and your week 4 visit that may take up to 4.5 hours.

Blood samples will be taken throughout the course of the study. Photographs of the full scalp, as well as eyebrows and eyelashes, for patients who have hair loss in these areas, will also be taken during the study. 

Your participation in this study is at no cost to you.

Compensation for travel and expenses may be provided if deemed eligible.


Visits
Drug administered on which days
Total
Length
Procedures
Study Length
Days
Every 4 weeks, for 32 weeks
Total
Up to 14 visits
Length
Visit duration is between approx. 1-3.5 hours
Procedures
Blood samples and photographs
Study Length
This study will last 1 year
Summary
We are currently recruiting subjects aged 18 to 65 years old with moderate-to-severe alopecia areata for a study that evaluates the safety, effectiveness, and tolerability of an investigational treatment called daxdilimab. Alopecia areata is an autoimmune disease resulting in hair loss that is usually in one or more coin-shaped patches on the face, scalp or other areas of the body that grows hair. It should be noted that subjects with the presence of traction alopecia would not be eligible for this study.
Condition
Alopecia areata
Treatment
Daxdilimab (there is no placebo)

There are 10 locations for this study

Burke Pharmaceutical Research

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States
Progressive Clinical Research

Progressive Clinical Research

San Antonio, Texas, 78213, United States
Dermatology Specialists of Spokane

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States
First OC Dermatology

First OC Dermatology

Fountain Valley, California, 92708, United States
Investigate MD

Investigate MD

Scottsdale, Arizona, 85255, United States
The Centre for Clinical Trials Inc.

The Centre for Clinical Trials Inc.

Oakville, Ontario, L6J 7W5, Canada
Innovaderm Research Inc.

Innovaderm Research Inc.

Montréal, Quebec, H2X 2V1, Canada
DS Research

DS Research

Louisville, Kentucky, 40241, United States
CenExel-FCR

CenExel-FCR

Tampa, Florida, 33606, United States
Dawes Fretzin Clinical Research Group, LLC

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States
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